K142386 is an FDA 510(k) clearance for the Operating Room Light Handle Adapter, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Litex Manufacturing, Inc. (Glendale, US). The FDA issued a Cleared decision on September 29, 2014, 33 days after receiving the submission on August 27, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K142386 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2014 |
| Decision Date | September 29, 2014 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |